Skip to content
← Full study record

NCT00047320 · OUTCOME

Progression-free Survival (PFS)

Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors · Source last updated 2018-02-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Probability
Interval / dispersion
95% Confidence Interval
Time frame
At 3 years from study entry

What was measured

Progression-free Survival was defined as time from study entry to disease progression or recurrence. Deaths that are clearly unrelated to disease progression, and second neoplasms are censored in this analysis. Progression -free survival was estimated by KM estimate.

Analysis population: Two ineligible patients were excluded. A total of 102 eligible patients were analyzed. one patient died without the disease progression reported. But the death was due to the disease. The death was counted as "event" when progression-free survival (PFS) was calculated. So EFS and PFS at 3 years were same.

Groups in this outcome

Radiation Therapy (CR From Induction)

Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC \> 750/L and platelets \> 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. carboplatin: Given IV etoposide: Given IV ifosfamide: Given IV thiotepa: Given IV adjuvant therapy conventional surgery neoadjuvant therapy peripheral blood stem cell transplantation radiation therapy: craniospinal irradiation

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Radiation Therapy (CR From Induction)102

Reported measurements

Source class 1
Values in Probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Radiation Therapy (CR From Induction)0.837Not reported0.7630.910Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.763
        upper Limit
        0.910
        value
        0.837
denoms
  1. counts
    1. group Id
      OG000
      value
      102
    units
    Participants
description
Progression-free Survival was defined as time from study entry to disease progression or recurrence. Deaths that are clearly unrelated to disease progression, and second neoplasms are censored in this analysis. Progression -free survival was estimated by KM estimate.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC \> 750/L and platelets \> 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. carboplatin: Given IV etoposide: Given IV ifosfamide: Given IV thiotepa: Given IV adjuvant therapy conventional surgery neoadjuvant therapy peripheral blood stem cell transplantation radiation therapy: craniospinal irradiation
    id
    OG000
    title
    Radiation Therapy (CR From Induction)
param Type
NUMBER
population Description
Two ineligible patients were excluded. A total of 102 eligible patients were analyzed. one patient died without the disease progression reported. But the death was due to the disease. The death was counted as "event" when progression-free survival (PFS) was calculated. So EFS and PFS at 3 years were same.
reporting Status
POSTED
time Frame
At 3 years from study entry
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
Probability

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice